Fixed-Dose Combinations Pragmatic Randomized Implementation Trial for Blood Pressure Control
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Provider nudge, Patient nudge, Pharmacist Virtual Visit.
- Who it may be relevant to
- Registry conditions: Hypertension, Primary Care. Basic parameters: 18 years — 80 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Pharmacy-led Intervention to Increase the Adoption of Fixed-dose Single Pill Blood Pressure Lowering Medications: Hybrid Effectiveness-Implementation Trial
Overview
The proposed study is an effectiveness-implementation hybrid type II trial designed to evaluate the impact of provider- and patient-directed interventions on FDC use. The trial will test the effectiveness of theory-driven nudges tailored to address provider and patient barriers. All interventions will be pharmacist-driven, with pharmacists delivering information via nudges to providers and via nudges or more intensive interventions (i.e., CPA) to patients. Data to evaluate outcomes will be extracted from electronic health records.
Interventions
- Behavioral Provider nudge
Pharmacists will deliver targeted nudges to providers through clinical decision support integrated into the electronic health record (EHR) - Behavioral Patient nudge
Patients will receive pharmacist-delivered nudges (e.g., text messages) 1-7 days before their visit to encourage fixed-dosed combinations - Behavioral Pharmacist Virtual Visit
Patients will receive pharmacist counseling and prescribing delivered via virtual encounters after their visit
Primary outcome measures
- Change in systolic blood pressure [Time frame: 6 months]
Secondary outcome measures (4)
- Change in diastolic blood pressure [Time frame: 6 months]
- Percentage of patients with well-controlled blood pressure [Time frame: 6 months]
- PCP level adoption: FDC prescribing; FDC discussion in EHR notes [Time frame: 6 months]
- Patient level adoption: FDC adherence (fill) [Time frame: 6 months]
Eligibility criteria
Inclusion criteria
- patients with documented hypertension diagnosis
- had an elevated ambulatory blood pressure reading during the qualifying visit (systolic >140 mmHg or diastolic >90 mmHg
- have an upcoming scheduled visit
- have an active prescription for 1 blood pressure lowering medication with a fixed-dose combination (FDC) alternative
Exclusion criteria
- have received a prescription for a FDC in the preceding two years
- reside in a nursing home
- have a documented allergy to any FDC components
- are pregnant
- preferred language is not English or Spanish, defined as documentation in the EHR indicating a primary language other than English or Spanish, or a documented request for an interpreter in a language other than Spanish
- have a diagnosis of heart failure or renal failure, given that antihypertensive management in these populations typically requires disease-specific regimens and more frequent treatment adjustments
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Health services research
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07228065 · 2025P002849 · 2P30AG064199